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Vigil
Vigil is a Biologic drug developed by Gradalis, Inc.. It is currently in Phase 3 development. Also known as: formerly known as FANG™, bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy, formerly known as FANG™ vaccine, Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy.
Vigil is a treatment being studied for various conditions, including obesity, melanoma, and healthy subjects, in combination with Pembrolizumab. The term "Vigil" is also used to describe a period of purposeful sleeplessness or devotional watching, unrelated to the treatment.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Vigil |
|---|---|
| Also known as | formerly known as FANG™, bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy, formerly known as FANG™ vaccine, Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy, bi-shRNAfurin and GMCSF Augmented Autologous Tumor |
| Sponsor | Gradalis, Inc. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Trial of Vigil for Participants With Ovarian Cancer (PHASE2)
- A Trial of FANG™ Vaccine for Participants With Ovarian Cancer (PHASE2)
- Expanded Access of Vigil in Solid Tumors
- The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil (NA)
- Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin
- Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany) (PHASE1)
- A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide (PHASE3)
- A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vigil CI brief — competitive landscape report
- Vigil updates RSS · CI watch RSS
- Gradalis, Inc. portfolio CI
Frequently asked questions about Vigil
What is Vigil?
Who makes Vigil?
Is Vigil also known as anything else?
What development phase is Vigil in?
Related
- Manufacturer: Gradalis, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: formerly known as FANG™, bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy, formerly known as FANG™ vaccine, Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy, bi-shRNAfurin and GMCSF Augmented Autologous Tumor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing